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NCT00032825 · ClinicalTrials.gov registry record · Phase 1
Ketoconazole Plus Docetaxel to Treat Prostate Cancer
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 674
- Enrollment target
NCT00032825: Completed Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT00032825 is a Phase 1 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 674 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00032825, a Phase 1 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 674 participants
- Enrollment target
Study Summary
This study will determine the maximum dose of docetaxel that can be given safely in combination with ketoconazole for treating advanced prostate cancer. Docetaxel is approved for the treatment of several other types of cancers; ketoconazole is an approved antifungal medication that is also commonly used in high doses to treat prostate cancer. Patients 18 years of age and older with advanced prostate cancer that does not respond to hormone therapy may be eligible for this study. Candidates will be screened with blood tests to evaluate liver, kidney and other organ function and with x-rays, scans, or other imaging tests to determine the extent of disease. Participants will take the following medications: * Docetaxel daily, infused through a vein over 30 minutes, in 4-week cycles-3 consecutive weeks of drug followed by one week of rest * Dexamethasone, 12 hours and 1 hour before and 12 hours after docetaxel infusions to help prevent fluid retention caused by the docetaxel * Ketoconazole, 3 times a day * Hydrocortisone, twice a day to replace a loss of natural steroids caused by the ketoconazole Patients will be hospitalized 1 to 2 days each for the first and second doses of docetaxel to allow for frequent blood draws to measure blood levels of the drug. Ketoconazole will be started about 2 weeks after the first dose of docetaxel and the second dose of docetaxel will be given 2 days after that. In order to determine the maximum tolerated dose of docetaxel, the first few patients in the study will be given a low dose of the drug, and subsequent patients will get increasingly higher doses until unacceptable side effects occur. Because prostate cancer cells may grow if exposed to testosterone, patients may have to have their testosterone production suppressed either surgically (removal of the testicles) or medically with an injection of leuprolide or goserelin, which are luteinizing hormone-release hormone agonists that reduce the amount of testosterone. Imaging studi
Interventions
- DRUG Docetaxel
- DRUG Ketaconazole
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 674 participants |
| Start Date | 2002-03-19 |
| Est. Completion | 2011-06-13 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00032825
The ClinicalTrials.gov registry entry for NCT00032825 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 674 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Docetaxel is the first listed.
NCT00032825 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00032825 about?
NCT00032825 is a clinical study titled "Ketoconazole Plus Docetaxel to Treat Prostate Cancer". This study will determine the maximum dose of docetaxel that can be given safely in combination with ketoconazole for treating advanced prostate cancer. Docetaxel is approved for the treatment of several other types of cancers; ketoconazole is an approved antifungal medication that is also commonly ...
What is the current status of trial NCT00032825?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 674 participants. The study started on 2002-03-19. Estimated completion is 2011-06-13.
What interventions are being tested in trial NCT00032825?
The interventions under investigation include: Docetaxel (DRUG), Ketaconazole (DRUG).
Who is sponsoring clinical trial NCT00032825?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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